Merge Healthcare, Inc.: Medical Device Recall in 2016 - (Recall #: Z-2363-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.

Product Classification:

Class II

Date Initiated: February 5, 2016

Date Posted: August 17, 2016

Recall Number: Z-2363-2016

Event ID: 74776

Reason for Recall:

When measuring a lesion on an unmagnified mammography image then performing the same measurement on an image magnified by the Hologic imager (different image), the measurements are not the same.

Status: Terminated

Product Quantity: 49 sites potentially have the affected versions

Code Information:

Software versions 6.0.2.0 MR2, 6.0.3.0 MR3, 6.0.3.1 MR3 CU1

Distribution Pattern:

Worldwide Distribution -- USA and Australia.

Voluntary or Mandated:

Voluntary: Firm initiated